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Monoclonal Antibodies

Ianalumab for Systemic Sclerosis

Phase 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disease duration of =< 18 months defined as time from the first non-Raynaud phenomenon manifestation

Male and female participants >= 18 and =< 70 years (at the time of the screening visit).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4, week 8, week 12, week 24, week 36, week 52, week 64, week 76, week 88, week 104, week 108, week 112, week 116, week 120, week 124 and week 208

Summary

This trial will test how well a medication called ianalumab works in patients with a type of autoimmune disease called diffuse cutaneous systemic sclerosis. The researchers will look at how effective, safe, and

Who is the study for?

This trial is for adults aged 18-70 with diffuse cutaneous systemic sclerosis, a type of scleroderma. Participants must have interstitial lung disease, ATA autoantibody positivity, and a specific disease duration and severity as measured by skin thickness score (mRSS). They should not have had the condition for more than 60 months.

What is being tested?

The study tests Ianalumab's effectiveness compared to a placebo in treating systemic sclerosis. It measures how well it works, its safety, and if there are any negative effects when given subcutaneously (under the skin) to participants.

What are the potential side effects?

While specific side effects are not listed here, typically such interventions may cause injection site reactions, allergic responses, potential immune system changes leading to increased risk of infections or other autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition started less than 18 months ago, not counting Raynaud's phenomenon.

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I am between 18 and 70 years old.

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My symptoms started less than 5 years ago, not counting Raynaud's.

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I have interstitial lung disease and positive for ATA autoantibodies.

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I have been diagnosed with systemic sclerosis according to specific criteria.

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My skin has gotten significantly tighter in the last 6 months.

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Two new parts of my body have been affected in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4, week 8, week 12, week 24, week 36, week 52, week 64, week 76, week 88, week 104, week 108, week 112, week 116, week 120, week 124 and week 208

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 4, week 8, week 12, week 24, week 36, week 52, week 64, week 76, week 88, week 104, week 108, week 112, week 116, week 120, week 124 and week 208

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, week 8, week 12, week 24, week 36, week 52, week 64, week 76, week 88, week 104, week 108, week 112, week 116, week 120, week 124 and week 208 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

3/5 rCRISS25 response

Secondary study objectives

Change from baseline in FVC% predicted at Week 52

Change from baseline in HAQ-DI at Week 52

Change from baseline in mRSS at Week 52

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VAY736 (Ianalumab)Experimental Treatment1 Intervention

Treatment Period 1: Ianalumab subcutaneous (s.c.) injection as defined in the protocol Treatment Period 2: Open-label (OL) Ianalumab subcutaneous (s.c.) injection as defined in the protocol

Group II: PlaceboPlacebo Group2 Interventions

Treatment Period 1: Placebo to Ianalumab subcutaneous (s.c.) injection as defined in the protocol Treatment Period 2: Open-label (OL) Ianalumab subcutaneous (s.c.) injection as defined in the protocol

0 / 7Eligibility criteria met